Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Sponsor

Qurient Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05394103

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901

Condition or Disease	Intervention/Treatment	Phase
Advanced Cancer Metastatic Cancer	Drug: Q901	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase 1/2 Multicenter, Open-label, Dose-escalation, Safety, Pharmacodynamic, and Pharmacokinetic Study of Q901 Administered Via Intravenous Infusion in Adult Patients With Selected Advanced Solid Tumors With a Cohort Expansion at the Recommended Phase 2 Dose

Anticipated Study Start Date :

Aug 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Aug 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose escalation (Q901)	Drug: Q901 The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter

Arm

Intervention/Treatment

Experimental: Dose escalation (Q901)

Drug: Q901

The study drug Q901 will be administered by IV infusion over a 30-minute period using a QW dosing schedule for 4 weeks, followed by a Q2W interval dosing schedule thereafter

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [28 days of cycle 1 (each cycle is 28 days)]

Secondary Outcome Measures

Change in the area under curve (AUC) of Q901 [Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
Change in the maximum plasma concentration (Cmax) of Q901 [Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
Change in the time of maximum plasma concentration (Tmax) of Q901 [Cycle 1 Day 1 and Day 22, Cycle 2 Day 8 and Day 22 (each cycle is 28 days)]
Tumor response using RECIST version 1.1 throughout study [Baseline and at the end of every even cycle up to approximately 2 years (each cycle is 28 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit
Measurable disease per RECIST v 1.1
ECOG performance status 0,1 or 2
Life expectancy of at least 3 months
Age ≥ 18 years
Signed, written IRB-approved informed consent form

Exclusion Criteria:

New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of >470 msec (females) and >450 msec (males)
Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
Active, poorly controlled autoimmune or inflammatory diseases

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Qurient Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qurient Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05394103

Other Study ID Numbers:

QRNT-009

First Posted:

May 27, 2022

Last Update Posted:

May 27, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasm Metastasis

Study Results

No Results Posted as of May 27, 2022